Approval
On December 19, 2017, the FDA approved Merck & Co. and Pfizer's new diabetes drug, Steglatro, and its two combination versions, Steglujan and Segluromet. These drugs are classified as sodium/glucose cotransporter 2 (SGLT2) inhibitors, and will be available this coming January.
Steglatro consists of ertugliflozin, while Steglujan … [Read more...]

SGLT2 Inhibitors: A New Side Effect
In previous articles, I have discussed SGLT2 inhibitor diabetes drugs such as Invokana, Farxiga, and Jardiance and the adverse events associated with them. Such side effects include diabetic ketoacidosis (DKA) and lower-limb amputations.
A recent study identified a new possible side effect of these drugs … [Read more...]

Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs.
If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]

Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes.
In December 2015 the FDA issued this Drug Safety Communication: “FDA revises labels of SGLT2 inhibitors for diabetes to include warnings … [Read more...]

Earlier today, February 10, 2017, the European Medicines Agency (EMA) released the findings of their Pharmacovigilance Risk Assessment Committee (PRAC) concerning the link between particular diabetes drugs and an increased risk of toe amputation.
These diabetes drugs are part of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of … [Read more...]

Attorney Tom Lamb

Mr. Lamb is recognized by other lawyers as practicing law at the highest level of professional experience in terms of legal ability and ethical standards — which is indicated by an AV® Preeminent™ 5.0 out of 5 rating (highest classification) rating from the Martindale-Hubbell® Lawyer Directory.

More importantly, he received the Martindale-Hubbell® Client Distinction Award, which recognizes excellence for: